About this trial
The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle stiffness) in people with lower limb spasticity. The study will also look at how VTS affects walking speed. The main questions it aims to answer are:
* Which areas of the body are the best for applying VTS? * Does VTS help improve walking speed in people with lower limb spasticity?
Participants will:
* Receive 15 minutes of VTS treatment on different parts of the body * Use the VTS device for 60 minutes during supervised lab sessions and at home (at rest and while walking) * Complete a daily log of how much time the device was used for and note any issues or difficulties the participant experience * Complete assessments after the treatment to measure change in mobility * Complete surveys about how comfortable the device is to use
Eligibility criteria
Qualifiers
≥6 months following neurologic diagnosis leading to spasticity
Modified Ashworth Scale (MAS) score of 3 or lower on ankle plantar flexor.
Ability to stand (with or without assistance) and lie supine.
Able to understand and comply with study procedures.
Disqualifiers
Uncontrolled systemic illness or serious medical conditions that could interfere with study procedures.
Previous surgery to treat spasticity in the affected lower limb.
Prior Botulinum Toxin (BoNT) therapy in the target limb within 4 months.
Unstable medication regimens for spasmolysis or muscle relaxation.
Trial design
Treatments tested in this trial
- Vibrotactile Stimulation (Static Use)
- Vibrotactile Stimulation (Dynamic Use)
- Vibrotactile Stimulation (Neurophysiological Mechanism)
Treatment groups
Sponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator